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Recall Observatory FDA recall evidence

Device product

108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326

Z-1592-2015

April 20, 2015

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 71028
Status
Terminated
Classification
Class II
Quantity
13,800 units
Official record key
device-enforcement:Z-1592-2015

Official wording

Reason: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Code information: Lot No. 2997915 2997919 2997920 2998568 2998569 3001232 3001233 3001234 3004257 3015880 3015881 3019519 3020159

Distribution pattern: Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.